Method and apparatus for inserting a filled prosthetic bladder into a patient

ABSTRACT

The apparatus includes a funnel member, a coupling member and retractors. The funnel member is flexible and is frusto-conical in shape. The funnel member proximal end opening is larger than the distal end opening. The funnel member couples to a distal or coupling member that is located at the funnel member distal end portion. The distal or coupling member is rigid and has catches for removably coupling to the retractors. In use, the retractors anchor the apparatus to the patient while allowing the funnel member to be manipulated to force the prosthesis into a surgical cavity of a patient.

This application is a continuation-in-part application of application Ser. No. 13/197,020, filed Aug. 3, 2011, which claims the benefit of provisional application, U.S. Ser. No. 61/371,218, filed Aug. 6, 2010.

FIELD OF THE INVENTION

The present invention relates to method and apparatuses for inserting prosthetic bladders, such as breast prostheses, into humans.

BACKGROUND OF THE INVENTION

Breast prostheses, or implants, are used in reconstructive and cosmetic surgery. A breast prosthesis is bladder-like, having an outer casing or membrane and an inner fluid substance. The inner fluid is either saline or silicone. The implants are inserted into cavities or pockets in the patient.

A saline implant can be inserted into a cavity in an empty configuration; once in place in the cavity, the implant is then filled with saline solution.

Preferably, the incision in the patient is small. Small incisions heal faster and are less unsightly. A saline prosthesis is relatively easy to implant through a small incision, as the bladder is unfilled and therefore small in size as it passes through the incision.

On the other hand, silicone implants are prefilled. Consequently, silicone implants are more difficult to pass through a small incision.

Keller, U.S. Publication No. 2009/0204107 discloses a device and method used to insert a silicone implant. While the device is useful, it suffers from some drawbacks. The device is used in a wet condition in order to ease the insertion of the implant. The wet condition reduces friction of the implant sliding through the device. Consequently, the device becomes slippery and is difficult to maintain in the incision. The device has no means of fixation to the patient or the incision, allowing it to slip out and contaminate the implant with skin bacteria. The Keller funnel also requires the surgeon to trim the funnel for each implant. Tape is used to form the funnel. The design relies on the tape maintaining the funnel's shape to break or “release” if the pressure on the implant becomes too great during the implant insertion process.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the insertion apparatus.

FIG. 2 is a close up view of the lower portion, or distal end, of the insertion apparatus.

FIG. 3 is a cross-sectional view of the insertion apparatus, taken along the funnel member and coupling member.

FIG. 4 is a cross-sectional view of the apparatus illustrating its use to insert a prosthesis into a body cavity.

FIG. 5 is a close up view of the lower portion, or distal end, of the apparatus in accordance with another embodiment.

FIG. 6 is a cross-sectional view taken at lines VI-VI of FIG. 5.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the figures, the apparatus 11 is used to insert bladder-type prostheses 15 into a pocket or cavity 16 (see FIG. 4) of patients. The apparatus has a funnel member 17, a coupling member 18 and retractors 19.

The funnel member 17 is generally frusto-conical in shape, having proximal and distal ends 21, 23. The proximal and distal ends each have openings 25, 27, with the proximal opening 25 being larger in diameter than the distal opening 27.

The funnel member 17 is made of a sheet material such as plastic. For example, nylon can be used. The plastic may be strengthened or reinforced with fibers. The funnel member 17 is flexible. For example, the funnel member can be bent over onto itself and when it contains a prosthesis, can be squeezed about the prosthesis. The funnel member can also be twisted. Both squeezing and twisting are used to force the prosthesis into the body cavity.

The inner surface 29 of the funnel member 17 is preferably slick so as to allow the unhindered passage of the prosthesis. For example, a coating of surgical lubricant can be used on the inner surface. As an alternative, the funnel member can be provided with a coating that becomes slick when wet. In still another alternative, the prosthesis can be provided with a slick surface, such as a surgical lubricant. Still another alternative, without a lubricant, is discussed in more detail below.

The coupling member 18 is generally frusto-conical in shape and has an upper end 31 and a lower end 33 (referring to the orientation shown in the FIGS.). The upper and lower ends 31, 33 have respective openings, with the upper end opening being larger in diameter than the lower end opening. The lower end portion of the coupling member can have a short section 35 extending from the lower end toward the upper end, which section has a constant inside diameter as shown in FIG. 4. Alternatively, the interior of the coupling member can have a sloped configuration all the way to the lower end.

The outside of the coupling member has “L” shaped catches 37. Each catch 37 has a short segment 39 that extends out from the coupling member and a longer segment 41 that extends parallel to a tangent of the exterior of the coupling member. An opening 42 is formed between the free end of the longer segment 41 and the body of the coupling member.

The coupling member is made of a rigid material such as metal (for example, stainless steel) or plastic.

The retractors 19 removably couple to the coupling member 18 at the catches 37. In the preferred embodiment, the apparatus uses two retractors 19, although additional retractors could be used if needed. Alternatively, a single retractor could be used. Each retractor 19 has a handle 43, an intermediate portion 45 and a distal end 47. The retractors can have various shapes and sizes to match the particular application.

The handle 43 of each retractor is bent or angled relative to the intermediate portion 45. This is so that when the retractor is coupled to the coupling member, the handle extends laterally from the funnel member 17, as shown in FIG. 4, so as not to interfere with the surgeon manipulating the funnel member proximal end 21. The handle is used for the insertion of the retractor into the patient and in coupling the retractor to the coupling member 18. The distal end 47 in the retractor has a flange that is angled relative to the intermediate portion. The distal end is structured and arranged to be inserted into a cavity of a patient. The distal end has a lip 49 that is bent toward the handle and that helps maintain the distal end of the retainer beneath skin tissue of a patient. The intermediate portions 45 of the retractors form an interference fit with the catches 37. Each intermediate portion ingresses and egresses the respective catch through the opening 42. The retractors 19 are made of metal, such as stainless steel.

To assemble the apparatus, the funnel member 17 is inserted into the coupling member and secured thereto. Double sided surgical tape can be used to couple the distal end portion 23 of the funnel member 17 inside of the coupling member 18. Alternatively, the funnel member can be coupled to the coupling member by glue or adhesive, heat bonding or other coupling mechanism.

FIGS. 5 and 6 show the apparatus in accordance with another embodiment that uses an alternative to couple the funnel member to the coupling member. The coupling member 18A has catches near the proximal, or upper end, 31 (the catches are not shown in FIG. 5 or 6); the catches couple the retractors to the coupling member. The outside surface of the coupling member is provided with projections 71 that extend radially out and have an enlarged head 73. The distal end of the funnel member 17A is provided with longitudinally oriented slots 75 that extend from the distal end a short distance toward the proximal end of the funnel member. The slots 75 form flaps 77 in the distal end of the funnel member. Each flap has an opening that aligns with a respective projection 71 (see FIG. 6).

To couple the funnel member 17A to the coupling member 18A, the distal end of the funnel member is inserted all the way through the coupling member so that the flaps 77 project from the coupling member distal end (the proximal end of the funnel member 17A extending away from the coupling member proximal end as in FIG. 3). The flaps 77 are folded back onto the coupling member, with the projections 71 being located in the openings. The enlarged heads 73 retain the flaps to the coupling member.

As an alternative to the projections 71, the funnel member flaps 77 can be secured to the outside of the coupling member with tape, snaps, glue or adhesive, heat bonding or other coupling mechanisms.

To use the apparatus 11, an incision 61 is made in the patient's skin 63. The incision is of an appropriate length so as to allow insertion of the retractors 19 and the distal end of the coupling member 18, 18A. The distal ends 47 of the retractors 19 are used to open the incision and allow the insertion of the coupling member distal, or lower, end 33 therein. The distal ends 47 of the retractors are inserted into the incision and located under the skin tissue 63 (see FIG. 4) and moved to open the incision. The coupling member distal end 33 is inserted into the now open incision. Once inserted, the coupling member 18 is rotated (clockwise from the surgeon's perspective) to locate the retractor intermediate portions 45 into the catches 37. Alternatively, the coupling member can be kept stationary while the retractors 19 are moved into the catches. Still another alternative is to fit a retractor to a coupling member and insert the coupling member and retractor into the incision. The other retractor, already in the incision, is then coupled to the coupling member.

The prosthesis 15 is located in the funnel member 17. A pocket or cavity 16 is located under the skin tissue, which cavity is to receive the prosthesis. The proximal end 21 and adjacent portions of the funnel member 17 are squeezed and/or twisted to force the prosthesis 15 toward the distal ends 23, 33, and into the cavity 16. The prosthesis deforms to fit through the distal end opening 27.

As an alternative to using a surgical lubricant, no lubricant is used at all. Instead, the implant is fully coated in a sterilizing medium, such as povidone-iodine solution. The sterilizing medium or solution can be full strength (for example 7.5%-10% povidone-iodine), or diluted with sterile saline and/or an antibiotic solution. Povidone-iodine sterilizing solutions are commercially available and commonly used to sterilize a patient's skin before surgery as well as hand hygiene. Coating can occur by fully immersing the implant in the sterilizing solution or locating the implant in a sterilizing solution bath and turning the implant until all surfaces are coated. The implant is then located in the funnel member and inserted into the patient's cavity.

The advantage to this technique is believed to be reduced infections. Once the package containing the implant is opened, the implant is exposed to the operating room air and sterility may be compromised. By coating the implant in the sterilizing solution, sterility is maintained. The surgeon can use either gloved hands to move the implant from the sterilizing solution bath to the funnel member, or a sterilized tool like tongs. Also, with the use of the sterilizing solution, no lubricant is used or needed. The funnel member 17 is sterile.

The use of the sterilizing solution eases the passage of the implant through the funnel member. This means the surgeon exerts less force in squeezing and/or twisting the funnel member to insert the implant.

The apparatus 11 provides several advantages to the insertion procedure. One advantage is that the implant (prosthesis) can be inserted into a body cavity without the surgeon or assistant touching the implant. This technique provides a totally “no touch” technique for prosthesis insertion. Another advantage is that once the apparatus is located in the incision, it is anchored to the patient and will not pull out. This gives the surgeon something to push against as the prosthesis is forced into the patient cavity. Consequently, it simplifies the insertion process. The funnel member is subjected to squeezing and/or twisting as the prosthesis is forced into the patient. Under such handling, the surgeon may unintentionally produce a pulling force on the funnel member. Without the retractors and coupling member, the funnel member would be pulled from the incision, (possibly contaminating the prosthesis) whereupon the distal end of the funnel member would have to be relocated into the incision.

Another advantage of the apparatus is that the coupling member 18 reinforces the funnel member 17 so that the funnel member will not tear. Without the coupling member, the force of the prosthesis passing through the funnel member distal end occasionally caused the distal end 23 to tear. The coupling member prevents this and maintains the funnel member intact.

Once the prosthesis is located inside the cavity, the retractors are uncoupled from the coupling member by relative rotation between the coupling member and the retainers. The coupling member is then removed from the incision, followed by the retractors. The incision can then be closed.

If the coupling member 18 and funnel member 17 are designed for single use, they are disposed of. If either the coupling member or funnel member are designed for reuse, they are subjected to sterilization procedures.

An advantage of the insertion apparatus and method is that the implant and insertion apparatus can be properly sized with respect to each other. A manufacturer of implants can provide the properly sized apparatus with the implant. The use of the coupling member 18 acts as a sizing cuff on the end of the funnel member. The size of the cuff is matched to the size of the implant. For example, some implants are physically large and require a cuff with a larger diameter distal opening, while other implants are physically smaller and can use a cuff with a smaller distal opening. By matching the insertion apparatus to the size of the implant, the chance that the implant will be damaged by excessive squeezing and stress is minimized. The implant is subject to damage if the implant is mishandled. Possible mishandling includes subjecting the implant to undue stresses or pressures, such as may be caused by attempting to squeeze the implant through an opening that is too small. A surgeon may make an incision in the patient that is too small for the implant and thus much force is required to squeeze the implant into the cavity. With the apparatus, the implant is protected from undue squeezing by the provision of the properly sized apparatus. A surgeon need not guess at what the proper size opening should be for the specific implant. The major complication with implants is capsular contracture thought to be due to sub-clinical infection. Sub-clinical infection is most likely caused by pushing the implant through the skin incision, dragging natural skin bacteria (still present after proper skin preparation) into the pocket surgically created for the implant. Use of this device prevents the implant from coming in contact with the skin during the insertion process.

Although the insertion member has been described in conjunction with retractors, it may be used without retractors. The insertion member comprises in this embodiment a funnel member and a rigid distal member. The distal member may be the same as the coupling member 18, except that the provisions for coupling to the retractors are not needed. The advantage to using this apparatus is that it minimizes the amount of pressure that can be applied to the prosthesis during insertion into a patient. The distal member is sized according to the specific prosthesis (for example 440 cc). Thus during insertion, the prosthesis cannot be squeezed through an opening which is too small and is therefore not subjected to too much pressure or squeezing.

The foregoing disclosure and showings made in the drawings are merely illustrative of the principles of this invention and are not to be interpreted in a limiting sense. 

1. A method for inserting a prosthesis into a surgical cavity in a patient, comprising the steps of: a) providing an insertion member having a rigid distal end and a flexible proximal end; b) making an incision in the patient; c) inserting retractors and the distal end of the insertion member into the incision; d) anchoring the distal end of the insertion member to the patient by the retractors; e) locating a flexible bladder-type prosthesis into the insertion member; f) manipulating a proximal end of the insertion member to force the prosthesis through an opening in the insertion member distal end and into the surgical cavity.
 2. The method of inserting a prosthesis into a surgical cavity in a patient of claim 1, wherein the step of inserting retractors into the incision further comprises the step of grasping the retractors by a respective handle and inserting a distal end of each retractor into the incision.
 3. The method of inserting a prosthesis into a surgical cavity in a patient of claim 2, wherein the insertion member has a longitudinal axis extending between the distal end and the proximal end, wherein the step of anchoring the distal end of the insertion member to the patient by the retractors further comprises the step of rotating the distal end of the insertion member about the longitudinal axis.
 4. The method of inserting a prosthesis into a surgical cavity in a patient of claim 1, wherein the insertion member has a longitudinal axis extending between the distal end and the proximal end, wherein the step of anchoring the distal end of the insertion member to the patient by the retractors further comprises the step of rotating the distal end of the insertion member about the longitudinal axis.
 5. The method of inserting a prosthesis into a surgical cavity in a patient of claim 1, wherein the step of manipulating the proximal end of the insertion member to force the prosthesis into an opening in the insertion member distal end and into the surgical cavity further comprises the step of squeezing the proximal end of the insertion member.
 6. The method of inserting a prosthesis into a surgical cavity in a patient of claim 1, further comprising the step of coating the prosthesis in a sterilizing medium prior to locating the prosthesis in the insertion member.
 7. The method of inserting a prosthesis into a surgical cavity in a patient of claim 6, wherein the step of manipulating a proximal end of the insertion member to force the prosthesis through an opening in the insertion member distal end and into the surgical cavity relies only upon the sterilizing medium to ease the passage of the prosthesis through the insertion member.
 8. A method for inserting a prosthesis into a surgical cavity in a patient, comprising the steps of: a) providing an insertion member having a distal end and a flexible proximal end; b) making an incision in the patient; c) coating a flexible bladder-type prosthesis with the sterilizing medium; d) locating the coated prosthesis inside the insertion member and locating the distal end of the insertion member in the incision; e) manipulating the proximal end of the insertion member to force the coated prosthesis through an opening in the insertion member distal end and into the surgical cavity and relying only upon the sterilizing medium to ease the passage of the prosthesis through the insertion member.
 9. The method for inserting a prosthesis into a surgical cavity in a patient of claim 8, wherein the step of manipulating the proximal end of the insertion member to force the prosthesis into an opening in the insertion member distal end and into the surgical cavity further comprises the step of squeezing the proximal end of the insertion member. 